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GC Cell Immuncell-LC Injection is Reborn as Advanced Biopharmaceuticals
2021-08-30
GC Cell Immuncell-LC Injection is Reborn as Advanced Biopharmaceuticals
GC Cell obtained the advanced biopharmaceutical approval for Immuncell-LC injection on August 27 in accordance with the Act on the safety of and support for advanced regenerative medicine and advanced biopharmaceuticals (hereinafter referred to as the Advanced Regenerative-Bio Act).
After the enforcement of the Advanced Regenerative-Bio Act in August 2020, advanced biopharmaceuticals that have previously obtained product approval must submit a common technical document form and others within one year to obtain reapproval. Accordingly, Immuncell-LC injection is the only immune cell therapy that has been approved as advanced biopharmaceutical among biopharmaceutical companies in Korea.
The Immuncell-LC injection was the anticancer drug for hepatocellular carcinoma (HCC), which was first approved in 2007. It achieved annual sales of KRW 10 billion in 2015 for the first time in Korea as a Cell therapy drug, and has continued to grow steadily, then recorded annual sales of KRW 35.6 billion in 2020.
In particular, it has a track record of administration to more than 6,000 patients since its launch and is manufactured under strict quality control at the Cell Center, the largest cell therapy facility in Korea.
In the future, by utilizing Immuncell-LC injection production technology and commercialization know-how, we will step up as a global company by diversifying our business into the CDMO field specializing in Cell therapy, along with R&D for CAR-T treatment and off-the-shelf CAR-CIK.
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